Hengrui's CDK4/6 inhibitor first to reach Phase III

China-based Jiangsu Hengrui Medicine Co., Ltd (600276.SH)'s SHR6390, a cyclin-dependent kinase (CDK) 4/6 selective inhibitor, has entered into a Phase III clinical trial, according to the Chinadrugtrials.org website. The indication is for HR-positive, HER2-negative locally advanced or metastatic breast cancer.

Belonging to the silk/threonine protein kinase family, the CDK protein kinase family plays an important regulatory role in cell cycle and transcriptional processes for the regulation of intracellular and extracellular signalling, and is a hot target for anti-tumor therapies. Three CDK inhibitors are currently marketed globally: Pfizer's Ibrance (palbociclib), Novartis's Kisqali (ribociclib), and Eli Lilly's Verzenio (abemaciclib), all indicated as breast cancer treatments.

Ibrance is the only CDK4/6 inhibitor commercially available in China, where it was first approved in July 2018. Domestic firms with CDK4/6 inhibitors under development include Chia Tai Tianqing, Betta Pharma, Fosun Pharma, Sihuan Pharma, CStone Pharma, Beta Pharma, and Guangzhou BeBetter Medicine Technology Co., Ltd, in addition to Hengrui. Hengrui's SHR6390 is the first domestic CDK4/6 inhibitor to reach the Phase III clinical trial stage.


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